Prospective Observational Study of RA Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 19 - 90 |
| Updated: | 2/8/2019 |
| Start Date: | May 2, 2017 |
| End Date: | November 2027 |
| Contact: | Sherrie Edwards, BSDH |
| Email: | sherrie.edwards@unmc.edu |
| Phone: | 402-559-8140 |
Prospective Observational Study of Newly Diagnosed Rheumatoid Arthritis Patients
The primary goal of this study is to investigate lung disease, through pulmonary function and
high resolution chest CT, in newly diagnosed RA patients. Extra-articular disease occurs in
approximately 50% of RA patients, with the lung being a common site of involvement.
Investigators goal is to understand the prevalence of lung disease in early RA patients and
to better characterize it through questionnaires, imaging, and serum studies. Additionally,
the goal is to find novel biomarkers to predict lung disease in RA patients.
high resolution chest CT, in newly diagnosed RA patients. Extra-articular disease occurs in
approximately 50% of RA patients, with the lung being a common site of involvement.
Investigators goal is to understand the prevalence of lung disease in early RA patients and
to better characterize it through questionnaires, imaging, and serum studies. Additionally,
the goal is to find novel biomarkers to predict lung disease in RA patients.
The purpose of this study is to gather, in a prospective manner, information on patients with
newly diagnosed rheumatoid arthritis and their disease course.
Specific aims of the study are:
1. To determine whether anti-malondialdehyde-acetaldehyde (MAA) adduct antibody
concentrations predict CT changes consistent with RA-lung involvement.
2. To determine whether anti-MAA antibody concentrations predict pulmonary function
abnormalities in forced vital capacity (FVC), forced expiratory volume in 1 second
(FEV1), and diffusion lung capacity of carbon monoxide (DLCO) and decline in these
parameters at 1 year follow-up.
3. To characterize the prevalence and classification of lung disease in early RA patients.
4. To develop a cohort of newly diagnosed RA patients who can be followed long-term through
electronic medical record (EMR) surveys, and biobank samples
This study would be the first to look at the correlation of anti-MAA antibody with lung
disease.
The long-term goal of this study is to create an inception cohort of RA patients that can be
followed for many years to come. This would be done through electronic medical records (EMR)
and obtaining consent to contact patients in the future if needed. Subjects will be
separately consented for UNMC rheumatologic serum and tissue biobank (IRB#292-14-EP), which
would allow future use of early RA samples.
newly diagnosed rheumatoid arthritis and their disease course.
Specific aims of the study are:
1. To determine whether anti-malondialdehyde-acetaldehyde (MAA) adduct antibody
concentrations predict CT changes consistent with RA-lung involvement.
2. To determine whether anti-MAA antibody concentrations predict pulmonary function
abnormalities in forced vital capacity (FVC), forced expiratory volume in 1 second
(FEV1), and diffusion lung capacity of carbon monoxide (DLCO) and decline in these
parameters at 1 year follow-up.
3. To characterize the prevalence and classification of lung disease in early RA patients.
4. To develop a cohort of newly diagnosed RA patients who can be followed long-term through
electronic medical record (EMR) surveys, and biobank samples
This study would be the first to look at the correlation of anti-MAA antibody with lung
disease.
The long-term goal of this study is to create an inception cohort of RA patients that can be
followed for many years to come. This would be done through electronic medical records (EMR)
and obtaining consent to contact patients in the future if needed. Subjects will be
separately consented for UNMC rheumatologic serum and tissue biobank (IRB#292-14-EP), which
would allow future use of early RA samples.
Inclusion Criteria:
- Patients 19-90 years old with the ability to give informed consent.
- Diagnosis of RA established by a Rheumatologist using the 2010 ACR criteria within the
past 2 years.
Exclusion Criteria:
- Patients will be excluded if they have inflammatory arthritis that does not meet 2010
ACR criteria for RA.
- Patients will be excluded if they are pregnant.
We found this trial at
1
site
Emile St
Omaha, Nebraska 68198
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Tina Mahajan, MD
Phone: 402-559-8140
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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